United States Securities and Exchange Commission
Washington, D.C. 20549
Form 10-Q
(Mark One)
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2003
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________ to _____________
Commission file number 0-27354
Impax Laboratories, Inc.
-----------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 65-0403311
------------------------------- -------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
30831 Huntwood Avenue - Hayward, California 94544
------------------------------------------- ----------
(Address of principal executive offices) (Zip code)
Registrant's telephone number including area code (510) 476-2000
--------------
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports) and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
--- ---
Indicate by check mark whether registrant is an accelerated filer
(as defined in Rule 12b-2 of the Act.) Yes X No
--- ---
The number of shares outstanding of the registrant's common stock as of
April 22, 2003 was approximately 47,884,334.
-------------- ----------
IMPAX LABORATORIES, INC.
INDEX TO FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2003
PART I. FINANCIAL INFORMATION
PAGE
----
Item 1. Financial Statements:
Balance Sheets as of March 31, 2003 and December 31, 2002................................... 3
Statements of Operations for the Three Months Ended March 31, 2003 and 2002................. 4
Statements of Cash Flows for the Three Months Ended March 31, 2003 and 2002................. 5
Notes to Financial Statements............................................................... 6
Item 2. Management's Discussions and Analysis of Financial Condition and Results of Operations............ 10
Item 3. Quantitative and Qualitative Disclosure About Market Risk......................................... 14
Item 4. Controls and Procedures........................................................................... 14
PART II. OTHER INFORMATION AND SIGNATURES
Item 1. Legal Proceedings................................................................................. 15
Item 6. Exhibits and Reports on Form 8-K.................................................................. 21
Signatures ............................................................................................ 22
Certifications ............................................................................................ 23
PART I - FINANCIAL INFORMATION
------------------------------
ITEM 1. FINANCIAL STATEMENTS
IMPAX LABORATORIES, INC.
BALANCE SHEETS
(unaudited)
(in thousands, except share and per share data)
March 31, December 31,
2003 2002
----------- ------------
ASSETS
Current assets:
Cash and cash equivalents $ 11,224 $ 10,219
Accounts receivable, net 5,734 6,524
Inventory 12,788 10,478
Prepaid expenses and other assets 763 973
---------- ----------
Total current assets 30,509 28,194
Restricted Cash 10,000 10,000
Property, plant and equipment, net 36,974 37,065
Investments and other assets 967 807
Goodwill, net 27,574 27,574
Intangibles, net 667 763
---------- ----------
Total assets $ 106,691 $ 104,403
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Current portion of long-term debt $ 1,056 $ 861
Accounts payable 9,693 7,529
Notes payable 5,825 3,999
Accrued expenses and deferred revenues 10,570 10,859
---------- ----------
Total current liabilities 27,144 23,248
Refundable deposit 22,000 22,000
Long term debt 9,643 9,105
Deferred revenues and other liabilities 2,419 1,486
---------- ----------
61,206 55,839
---------- ----------
Commitments and Contingencies:
Mandatory redeemable convertible Preferred Stock:
Series 2 mandatory redeemable convertible Preferred Stock, $0.01
par value 75,000 shares outstanding at March 31, 2003,
and December 31, 2002, redeemable at $100 per share 7,500 7,500
---------- ----------
7,500 7,500
---------- ----------
Stockholders' equity:
Redeemable convertible Preferred Stock - -
Common stock, $0.01 par value, 75,000,000 shares authorized and
47,879,268 and 47,874,614 shares issued and outstanding
at March 31, 2003, and December 31, 2002, respectively 479 479
Additional paid-in capital 131,100 131,085
Unearned compensation (39) (158)
Accumulated deficit (93,555) (90,342)
---------- ----------
Total stockholders' equity 37,985 41,064
---------- ----------
Total liabilities and stockholders' equity $ 106,691 $ 104,403
========== ==========
The accompanying notes are an integral part of these financial statements.
IMPAX LABORATORIES, INC.
STATEMENTS OF OPERATIONS
(dollars in thousands, except share and per share data)
Three Months Ended
March 31,
------------------------------------
2003 2002
----------- -----------
Net sales $ 11,066 $ 3,432
Other revenues 359 --
----------- -----------
Total revenues 11,425 3,432
Cost of sales 8,147 3,139
----------- -----------
Gross margin 3,278 293
Research and development 3,755 2,890
Less: Teva payments (132) (166)
----------- -----------
Research and development, net 3,623 2,724
Selling expenses 568 658
General and administrative expenses 2,122 2,170
Other operating income (expense), net 11 (30)
----------- -----------
Net loss from operations (3,024) (5,289)
Interest income 42 235
Interest expense (231) (367)
----------- -----------
Net loss $ (3,213) $ (5,421)
=========== ===========
Net loss per share (basic and diluted) $ (0.07) $ (0.12)
=========== ===========
Weighted average common shares outstanding 47,876,830 46,812,977
=========== ===========
The accompanying notes are an integral part of these financial statements.
IMPAX LABORATORIES, INC.
STATEMENTS OF CASH FLOWS
(unaudited)
(dollars in thousands)
Three Months Ended
March 31,
---------------------------------
2003 2002
-------- --------
Cash flows from operating activities:
Net loss $ (3,213) $ (5,421)
Adjustments to reconcile net loss to net cash used by operating activities:
Depreciation and amortization 885 512
Non-cash compensation charge (warrants and options) 119 120
Change in assets and liabilities:
Accounts receivable 790 101
Inventory (2,310) (409)
Prepaid expenses and other assets 50 (824)
Accounts payable and other liabilities 2,808 2,796
-------- --------
Net cash used in operating activities (871) (3,125)
-------- --------
Cash flows from investing activities:
Purchases of property and equipment (698) (5,600)
Sale and maturities of short term investments - 11,647
-------- --------
Net cash (used in) provided by investing activities (698) 6,047
-------- --------
Cash flows from financing activities:
Notes payable borrowings 1,826 -
Additions to long-term debt 896 -
Repayment of long-term debt (163) (72)
Proceeds from sale of common stock - 3,750
Proceeds from issuance of common stock (upon exercise of
stock options and warrants and under ESPP) 15 256
-------- --------
Net cash provided by financing activities 2,574 3,934
-------- --------
Net increase in cash and cash equivalents 1,005 6,856
-------- --------
Cash and cash equivalents, beginning of the quarter $ 10,219 $ 15,044
-------- --------
Cash and cash equivalents, end of the quarter $ 11,224 $ 21,900
======== ========
Cash paid for interest $ 232 $ 101
======== ========
The accompanying notes are an integral part of these financial statements.
NOTES TO FINANCIAL STATEMENTS
Three Months Ended
March 31, 2003
Note 1. The financial statements included herein have been prepared by the
Company pursuant to the rules and regulations of the Securities and Exchange
Commission. Certain information and disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
have been condensed or omitted pursuant to such rules and regulations; however,
the Company believes that the disclosures are adequate to make the information
presented not misleading. It is suggested that these financial statements be
read in conjunction with the financial statements and the notes thereto included
in the Company's latest Annual Report on Form 10-K. The results of operations
for the three months ended March 31, 2003 are not necessarily indicative of the
results of operations expected for the year ending December 31, 2003.
Impax Laboratories, Inc.'s ("IMPAX," "we," "us," or "the Company") main business
is the development, manufacturing, and marketing of specialty prescription
pharmaceutical products utilizing its own formulation expertise and drug
delivery technologies. The Company is currently marketing twenty-seven generic
pharmaceuticals, which represent dosage variations of twelve different
pharmaceutical compounds, and has nineteen applications under review with the
Food and Drug Administration (FDA), addressing approximately $6 billion in U.S.
product sales in the twelve months ending December 31, 2002. Fourteen of these
were filed under Paragraph IV of the Hatch-Waxman Amendments. The Company has
approximately fifteen other products in various stages of development for which
applications have not yet been filed. The products are generic versions of brand
name pharmaceuticals that had U.S. sales of $3.6 billion in the twelve months
ending December 31, 2002.
We have experienced, and expect to continue to experience, operating losses and
negative cash flow from operations and our future profitability is uncertain. We
do not know whether or when our business will ever be profitable or generate
positive cash flow, and our ability to become profitable or obtain positive cash
flow is uncertain. We have generated minimal revenues to date and have
experienced operating losses and negative cash flow from operations since our
inception. As of March 31, 2003, our accumulated deficit was $93,555,000 and we
had outstanding indebtedness in an aggregate principal amount of $38,524,000,
including the $22,000,000 refundable deposit from Teva. To remain operational,
we must, among other things:
o continue to obtain sufficient capital to fund our operations;
o obtain from the FDA approval for our products;
o prevail in patent infringement litigation in which we are involved;
o successfully launch our new products; and
o comply with the many complex governmental regulations that deal with
virtually every aspect of our business activities.
We expect to incur significant operating expenses, particularly research and
development, for the foreseeable future in order to execute our business plan.
We, therefore, anticipate that such operating expenses, as well as planned
capital expenditures, will constitute a material use of our cash resources.
The $22 million refundable deposit from Teva, less any forgiven amounts upon
IMPAX's attainment of certain milestones, if any, is due and payable on January
15, 2004, in cash or equity at our discretion. As of April 28, 2003, we believe
that up to $10.5 million of the $22 million may be forgiven prior to January 15,
2004, although there is no assurance that any of the $22 million may be
ultimately forgiven. These milestone events, if achieved, will represent the
culmination of a separate earnings process. We currently plan to repay the
refundable deposit to Teva in stock. Accordingly, we have classified the
refundable deposit as long-term in the accompanying balance sheet as of March
31, 2003. The price of the common stock for purposes of repaying any amounts
owed under the loan will be the average closing sale price of our common stock
measured over a ten-trading-day period ending two days prior to January 15,
2004. However, if any of the shares we issue to Teva as repayment of the loan
will cause Teva to own in excess of 19.9% of our outstanding common stock, we
will have to repay that portion of the loan in excess of 19.9% in cash. If we
repay the loan in stock, such payment will result in dilution. If we repay all
our portion of the loan in cash, we may seek additional sources of liquidity to
fund such payment, discussed below.
Although our existing cash and cash equivalents are expected to decline during
the remainder of 2003, we believe that our existing cash and cash equivalent
balances, together with our $25 million term loan and revolving line of credit,
will be sufficient to meet our operational plan for the next twelve months. We
may, however, seek additional financing through strategic alliances and/or
equity markets to repay the Teva deposit, if required, and to fund our research
and development plans, and potential revenues shortfall due to delays in new
products introduction. However, we may be unable to obtain such financing.
To date, the Company has funded its research and development and other operating
activities through equity and debt financings and strategic alliances.
Note 2. The major operational highlights for the three months ended March 31,
2003, included the following:
o In January 2003, the FDA granted final approval to the Company's
Abbreviated New Drug Application (ANDA) for a generic version of Rilutek(R)
(Riluzole 50mg) tablets. Aventis markets Rilutek(R) for the treatment of
amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.
Approval followed the expiration of Aventis' Orphan Drug Exclusivity on
December 12, 2002. According to IMS Health, U.S. sales of Rilutek(R) were
$35 million for the twelve months ended December 31, 2002.
o In January 2003, the FDA granted final approval to the Company's ANDA for a
generic version of Claritin-D(R) 12-hour (Loratadine/Pseudoephedrine
sulfate, 5mg/120mg) Extended Release Tablets. FDA approved a switch in
Claritin-D(R) 12-hour's status from a prescription drug to an
over-the-counter (OTC) drug for the relief of symptoms of seasonal allergic
rhinitis (hay fever) on December 9, 2002.
o Also in January 2003, Abbott Laboratories filed a lawsuit against the
Company in the federal district court of Delaware alleging patent
infringement related to IMPAX's filing of an ANDA for a generic version of
the cholesterol drug Tricor(R) Tablets. Tricor(R) is a treatment for very
high serum triglyceride levels. U.S. sales of Tricor(R) 160mg Tablets were
approximately $411 million for the twelve months ended December 31, 2002,
according to IMS Health.
o In February 2003, Merck & Co., Inc. filed a lawsuit against the Company in
the federal district court in Delaware alleging patent infringement related
to IMPAX's filing of an ANDA for a generic version of Sinemet(R) CR
Tablets. Sinemet CR is used to treat patients with Parkinsonism. U.S. sales
of Sinemet CR and the currently marketed generic equivalent were
approximately $154 million in the twelve months ended December 31, 2002,
according to IMS Health. In April 2003, Merck & Co., Inc. has withdrawn its
lawsuit alleging patent infringement related to our filing of the ANDA for
a generic version of Sinemet(R) CR Tablets.
o In March 2003, U.S. District Judge Joan B. Gottschall in Chicago ruled that
our Fenofibrate Capsules, a generic form of Tricor(R) Micronized Capsules,
does not infringe Abbott Laboratories' patent on this product. Tricor is
marketed for the treatment of hypercholesterolemia and
hydertriglyceridemia. According to IMS Health, U.S. sales of the capsule
for the lipid-regulating agent were approximately $3.2 million for the
twelve months ending December 31, 2002, as Abbott converted usage to the
tablet form prior to the availability of generic capsules.
o Subsequent to the end of the quarter ending March 31, 2003, on April 24,
2003 the FDA granted approval to the Company's ANDA for a generic version
of Mestinon(R) (Pyridostigmine Bromide) 60mg tablets. ICN Pharmaceuticals,
Inc. markets Mestinon(R) for symptomatic treatment of myasthenia gravis.
Myasthenia gravis is a neuromuscular disorder primarily characterized by
muscle weakness and rapid muscle fatigue. According to IMS Health, U.S.
sales of Mestinon(R) were $19 million for the twelve months ended December
31, 2002.
Note 3. In January 2003, following final approval from FDA and under the terms
of a non-exclusive Licensing Contract Manufacturing and Supply Agreement, we
commenced shipping the generic version of Claritin-D(R) 12-hour (loratadine and
pseudoephedrine sulfate) 5mg/120mg Extended Release Tablets to Schering-Plough
Corporation. Schering-Plough launched its OTC Claritin-D(R) 12-hour in March
2003.
Note 4. Our gross receivables and related deductions at March 31, 2003 and
December 31, 2002 are set forth below:
(in $000s) March 31, December 31,
2003 2002
-------- ------------
Gross accounts receivable $ 8,828 $ 9,827
Less: Accrued rebates (1,585) (1,525)
Less: Accrued chargebacks (1,137) (1,373)
Less: Other deductions (372) (405)
-------- --------
Net accounts receivable $ 5,734 $ 6,524
-------- --------
Other deductions include allowance for disputable items, doubtful accounts, and
cash discounts.
Chargebacks and Rebates Accruals activity at March 31, 2003 and December 31,
2002 is set forth below.
CHARGEBACKS ACCRUAL
-------------------
(in $000s) March 31, December 31,
2003 2002
-------- ------------
Beginning Balance $ 1,373 $ 580
Add: Provision related to sales made in current period 1,314 4,632
Less: Credits issued during the current period (1,550) (3,839)
-------- ---------
Ending Balance $ 1,137 $ 1,373
-------- ---------
REBATES ACCRUAL
----------------
(in $000s) March 31, December 31,
2003 2002
-------- ------------
Beginning Balance $ 1,525 $ 886
Add: Provision related to sales made in current period 1,062 4,095
Less: Credits issued during the current period (1,002) (3,456)
-------- ---------
Ending Balance $ 1,585 $ 1,525
-------- ---------
Note 5. Our inventory consists of the following:
March 31, December 31,
(in $000s) 2003 2002
-------- ------------
Raw materials......................................................... $ 7,080 $ 7,122
Work in process....................................................... 1,097 365
Finished goods........................................................ 4,970 3,191
-------- ---------
13,147 10,678
Less: Reserve for obsolete inventory and net realizable value (359) (200)
-------- ---------
$ 12,788 $ 10,478
======== =========
Note 6. Intangibles consist of the following:
Estimated March 31, December 31,
(in $000s) useful life 2003 2002
(years) --------- ------------
-----------
Product rights and licenses...................... 3 - 8 $ 2,691 $ 2,691
Less: Accumulated amortization (2,024) (1,928)
-------- ---------
$ 667 $ 763
======== =========
Amortization expense was $96,000 for the three months ended March 31, 2003.
Expected amortization expense for 2003 and 2004 is $384,000 and $379,000,
respectively. The existing intangible assets will be fully amortized by December
31, 2004.
Note 7. The Company accounts for stock-based employee compensation arrangements
in accordance with provisions of Accounting Principles Board (APB) Opinion No.
25, "Accounting for Stock Issued to Employees". Compensation cost for stock
options, if any, is measured as the excess of the quoted market price of the
stock at the date of grant over the amount an employee must pay to acquire the
stock. The Company has adopted the disclosure only provisions of SFAS No. 123,
"Accounting for Stock-Based Compensation" and SFAS No. 148, "Accounting for
Stock-Based Compensation - Transition and Disclosure - An Amendment to FASB
Statement No. 123."
Had compensation cost for the Company's Plans been determined based on the fair
value at the grant dates for the awards under a method prescribed by SFAS No.
123, the Company's loss would have been increased to the pro forma amounts
indicated below (in thousands):
3-Months Ended
March 31
--------------------------------
2003 2002
--------- ---------
Net loss, as reported $ (3,213) $ (5,421)
Add: Stock-based employee compensation
included in reported net income,
net of related tax effects -- --
Deduct: Total stock-based employee
compensation expense determined under
fair value based method for all awards,
net of related tax effects (862) (553)
--------- ---------
Pro forma net loss $ (4,075) $ (5,974)
========= =========
Earnings per share:
Basic - as reported $ (0.07) $ (0.12)
--------- ---------
Basic - pro forma $ (0.09) $ (0.13)
--------- ---------
Diluted - as reported $ (0.07) $ (0.12)
--------- ---------
Diluted - pro forma $ (0.09) $ (0.13)
--------- ---------
The Company calculated the fair value of each option grant on the date of the
grant using Black-Scholes pricing method with the following assumptions:
dividend yield at 0%; weighted average expected option term of five years;
risk-free interest rate of 2.69%. The expected stock price volatility for the
quarter ended March 31, 2003 was 69%. The weighted average fair value of options
granted for the quarter was $1.96.
Note 8. Commitments and Contingencies
Patent Litigation
As part of our patent litigation strategy, we have obtained two policies
covering up to $7 million of patent infringement liability insurance from
American International Specialty Line Company ("AISLIC"), an affiliate of AIG
International. This litigation insurance covers us against the costs associated
with patent infringement claims made against us relating to seven of the ANDAs
we filed under Paragraph IV of the Hatch-Waxman Amendments. At present, we
believe this insurance coverage is sufficient for our legal defense costs
related to these seven ANDAs. Correspondence received from AISLIC indicated
that, as of April 10 and 17, 2003, one of the policies had approximately
$1,651,000 remaining on the limit of liability and the second of the policies
had approximately $639,000 remaining on the limit of liability. In addition, as
per the agreement with Teva, for the six products already filed at the time of
the agreement, Teva will pay 50% of the attorneys' fees and costs in excess of
the $7 million to be paid by AISLIC. For the three products filed since the
agreement was signed, Teva will pay 45% of the attorneys' fees and costs, and
for the remaining three products, Teva will pay 50% of the attorneys' fees and
costs.
However, we do not believe that this type of litigation insurance will be
available to us on acceptable terms for our other current or future ANDAs. In
those cases, our policy is to record such expenses as incurred.
Although the outcome and costs of the asserted and unasserted claims is
difficult to predict because of the uncertainties inherent in patent litigation,
management does not expect the Company's ultimate liability for such matters to
have a material adverse effect on its financial condition, results of
operations, or cash flows.
FIN 45
In November 2002, the FASB issued FIN No. 45, "Guarantor's Accounting and
Disclosure Requirements for Guarantees, Including Indirect Guarantees of
Indebtedness of Others." Guarantees and claims arise during the ordinary course
of business from relationships with suppliers, customers, and strategic partners
when the Company undertakes an obligation to guarantee the performance of others
through the delivery of cash or other assets if specified triggering events
occur. Non-performance under a contract by the guaranteed party triggers the
obligation of the Company. We reviewed all material agreements and concluded
that all indemnifications are excluded from the FIN No. 45 scope of
interpretation since they relate primarily to our own future performance and do
not require any contingent payments.
FIN 46
We currently have no relationships with variable interest entities as defined in
FASB Interpretation No. 46, "Consolidation of Variable Interest Entities" as of
March 31, 2003.
Note 9. The Company reports both basic earnings per share, which is based on the
weighted-average number of common shares outstanding, and diluted earnings per
share, which is based on the weighted-average number of common shares
outstanding and all dilutive potential common shares outstanding. Because the
Company had net losses in each of the periods presented, only the weighted
average of common shares outstanding has been used to calculate both basic
earnings per share and diluted earnings per share, as inclusion of the potential
common shares would be anti-dilutive.
Mandatory redeemable convertible stock of 1,500,000 shares (on an as-converted
basis), warrants to purchase 2,548,266 shares, and stock options to purchase
5,775,889 shares were outstanding at March 31, 2003, but were not included in
the calculation of diluted earnings per share, as their effect would be
anti-dilutive.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
To the extent any statements made in this report contain information that is not
historical, these statements are forward-looking in nature and express the
beliefs, expectations or opinions of management. For example, words such as
"may," "will," "should," "estimates," "predicts" "potential," "continue,"
"strategy," "believes," "anticipates," "plans," "expects," "intends," and
similar expressions are intended to identify forward-looking statements. Such
statements are based on current expectations and involve a number of known and
unknown risks and uncertainties that could cause IMPAX's future results,
performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include, but are not limited to,
IMPAX's ability to obtain sufficient capital to fund its operations, the
difficulty of predicting Food and Drug Administration ("FDA") filings and
approvals, consumer acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, IMPAX's ability to successfully
develop and commercialize pharmaceutical products, IMPAX's reliance on key
strategic alliances, the uncertainty of patent litigation, the availability of
raw materials, the regulatory environment, dependence on patent and other
protection for innovative products, exposure to product liability claims,
fluctuations in operating results and other risks detailed from time to time in
IMPAX's filings with the Securities and Exchange Commission. Forward-looking
statements speak only as to the date on which they are made, and IMPAX
undertakes no obligation to update publicly or revise any forward-looking
statement, regardless of whether new information becomes available, future
developments occur or otherwise.
General
Impax Laboratories, Inc. was formed through a business combination on December
14, 1999 between Impax Pharmaceuticals, Inc., a privately held drug delivery
company, and Global Pharmaceutical Corporation, a generic pharmaceutical
company. Impax Pharmaceuticals, Inc. merged with and into Global, with Impax
stockholders receiving 3.3358 shares of Global common stock for each share of
Impax Pharmaceuticals, Inc. At the conclusion of the merger, Impax
Pharmaceuticals, Inc. stockholders held over 70% of the combined company. For
accounting purposes, the merger has been treated as a recapitalization of Impax
Pharmaceuticals, Inc. with Impax Pharmaceuticals, Inc. deemed the acquirer of
Global in a reverse acquisition. As a reverse acquisition, our historical
operating results prior to the merger are those of Impax Pharmaceuticals, Inc.
and only include the operating results of Global after the merger. In connection
with the merger, Global changed its name to Impax Laboratories, Inc.
We are a technology based, specialty pharmaceutical company applying formulation
and development expertise, as well as our drug delivery technology, to the
development of controlled-release and niche generics, in addition to the
development of branded products. We currently market twenty-seven generic
pharmaceuticals, which represent dosage variations of twelve different
pharmaceutical compounds, and have nineteen applications pending at the FDA,
including three tentatively approved, that address approximately $6 million in
U.S. product sales for the twelve months ended December 31, 2002. Fourteen of
these filings were made under Paragraph IV of the Hatch-Waxman Amendments. We
have approximately fifteen other products in various stages of development for
which applications have not yet been filed. These products are generic versions
of brand name pharmaceuticals that had U.S. sales of approximately $3.6 billion
for the twelve months ended December 31, 2002.
Results of Operations
We have incurred net losses in each year since our inception. We had an
accumulated deficit of $93,555,000 at March 31, 2003.
THREE MONTHS ENDED MARCH 31, 2003, COMPARED TO THREE MONTHS ENDED MARCH 31, 2002
Overview
The net loss for the three months ended March 31, 2003, was $3,213,000 as
compared to $5,421,000 for the three months ended March 31, 2002. The decrease
in the net loss was primarily due to increased sales, which were partially
offset by increases in research and development expenses.
Revenues
Revenues for the three months ended March 31, 2003, were $11,425,000 as compared
to $3,432,000 for the same period in 2002. The significant increase in net sales
was primarily due to Claritin-D(R) 12-hour over-the counter (OTC) Tablets
shipped to Schering-Plough, higher sales of Fludrocortisone Acetate Tablets
which were first introduced at the end of the first quarter of 2002, higher
Lipram sales, sales of Minocycline Hydrochloride Capsules which were first
launched in the third quarter of 2002, and lower product returns. Other revenues
represent milestone revenues recognized pursuant to strategic agreements with
Schering-Plough, Wyeth, and Novartis. The following table summarizes the
activity in net sales for the three months ended March 31, 2003 and 2002:
2003 2002
--------- -------
Product sales $ 14,153 $ 6,654
Less:
Rebates (1,062) (905)
Chargebacks (1,314) (870)
Actual returns (132) (326)
Increase in reserve for product return - (267)
Other credits (579) (854)
--------- -------
Net sales 11,066 3,432
Other Revenues 359 -
Total Revenues $ 11,425 $ 3,432
========= =======
The rebates, chargebacks and other credits decreased for the three months ended
March 31, 2003 to 22 percent of product sales as compared to 48 percent for the
comparable period in 2002. This decrease was mainly due to Claritin-D(R) 12-hour
Tablets sales which are exempt from rebates, chargebacks and other credits as
per the agreement with Schering-Plough.
Cost of Sales
The cost of sales for the three months ended March 31, 2003, was $8,147,000 as
compared to $3,139,000 for the same period in 2002. The overall increase in cost
of sales was primarily due to increased net sales.
Gross Margin
Gross margin for the three months ended March 31, 2003 was $3,278,000 as
compared to $293,000 for the same period in 2002. This increase of $2,985,000
over 2002 was primarily due to higher net sales and improved plant capacity
utilization.
Research and Development Expenses
The research and development expenses for the three months ended March 31, 2003,
were $3,755,000 less reimbursements of $132,000 by a subsidiary of Teva
Pharmaceutical Industries, Ltd. under the strategic alliance agreement signed in
June 2001, as compared to $2,890,000 less reimbursements of $166,000 for the
same period in 2002. The higher research and development expenditures in 2003
were attributable to higher cost of bio-studies and bio-analytical studies,
higher legal expenses related to patents and alleged patent infringement
lawsuits, and personnel costs.
Selling Expenses
The selling expenses for the three months ended March 31, 2003, were $568,000 as
compared to $658,000 for the same period in 2002. The decrease in selling
expenses as compared to 2002 was primarily due to lower market research and
sales commission costs.
General and Administrative Expenses
The general and administrative expenses for the three months ended March 31,
2002, were $2,122,000 as compared to $2,170,000 for the same period in 2002. The
decrease in general and administrative expenses as compared to 2002 was
primarily due to lower professional fees, and software expenses.
Interest Income
Interest income for the three months ended March 31, 2003, was $42,000 as
compared to $235,000 for the same period in 2002, primarily due to lower cash
equivalents and short-term investments, and lower interest rates.
Interest Expense
Interest expense for the three months ended March 31, 2003, was $231,000 as
compared to $367,000 for the same period in 2002. This decrease was due to the
elimination of the interest accrual on the refundable deposit with Teva. During
the fourth quarter of 2002, we received tentative or final approval on three
products, which met the condition that no future interest accrues on the
refundable deposit. The interest expense for 2003 relates primarily to the two
Cathay Bank loans, and the revolving credit facility and term loan agreement
signed with Congress Financial in October 2002. The following table summarizes
the activity for the three months ended March 31, 2003 and 2002:
2003 2002
-------- -------
Interest expense $ 231 $ 101
Interest on refundable deposit - 438
Forgiveness of interest on refundable deposit -
Less: amount capitalized (172)
------- -------
Total interest expense $ 231 $ 367
------- -------
Net Loss
The net loss for the three months ended March 31, 2003, was $3,213,000 as
compared to $5,421,000 for the same period in 2002. The decrease in the net loss
of $2,208,000 was primarily due to increased sales which were partially offset
by increases in research and development expenses. The 2003 results included a
benefit from the absence of the interest expense, less capitalized interest on
the refundable deposit from Teva of approximately $266,000.
Liquidity and Capital Resources
As of March 31, 2003, we had $11,224,000 in cash and cash equivalents.
The net cash provided by financing activities for the three months ended March
31, 2003, was approximately $2,574,000 consisting primarily of increases in net
borrowings of $1,826,000 from the revolving line of credit and additional
$896,000 in long-term debt from Congress Financial. During the three months
ended March 31, 2003, the increase in inventory was more than offset by the
increase in accounts payable and other liabilities.
Our capital expenditures for the three months ended March 31, 2003 were $698,000
as compared to $5,600,000 for the same period in 2002.
In October 2002, we signed a three-year, $25 million Loan and Security Agreement
with Congress Financial Corporation, comprised of a revolving loan of up to
$20,500,000, and a term loan of up to $4,500,000. The revolving loan is
collateralized by eligible accounts receivable and inventory, subject to
sublimits and other terms, and the term loan is collateralized by machinery and
equipment, with a 60-month amortization. In addition, a $10 million restricted
cash account was established as collateral for this credit facility to be
reduced based on meeting certain profitability targets. The interest rates for
the revolving loans range from prime rate plus 1% to 1.75%, or eurodollar rate
plus 3% to 3.75%, at our option, based on excess availability. The term loan has
an interest rate of prime rate plus 1.5%, or eurodollar rate plus 4%, at our
option. As of March 31, 2003, we borrowed approximately $5,825,000 against the
revolving credit line and $3,889,000 against the term loan. The revolving credit
facility and the term loan agreement have a number of quarterly covenants
primarily covering Minimum Tangible Net Worth, and either EBITDA or excess
availability and annual capital expenditures limit of $4 million. At March 31,
2003, all the bank loan covenants were met.
The $22 million refundable deposit from Teva, less any forgiven amounts upon
IMPAX's attainment of certain milestones, if any, is due and payable on January
15, 2004, in cash or equity at our discretion. As previously indicated in Note
1, as of April 28, 2003, we believe that up to $10.5 million of the $22 million
may be forgiven prior to January 15, 2004, although there is no assurance that
any of the $22 million may be ultimately forgiven. These milestone events, if
achieved, will represent the culmination of a separate earnings process. We
currently plan to repay the refundable deposit in stock. Accordingly, we have
classified the refundable deposit as long-term in the accompanying balance sheet
as of March 31, 2003. The price of the common stock for purposes of repaying any
amounts owed under the loan will be the average closing sale price of our common
stock measured over a ten-trading-day period ending two days prior to January
15, 2004. However, if any of the shares we issue to Teva as repayment of the
loan will cause Teva to own in excess of 19.9% of our outstanding common stock,
we will have to repay the portion of the loan in cash. If we repay the loan in
stock, such payment will result in dilution. If we repay all our portion of the
loan in excess of 19.9% in cash, we may seek additional sources of liquidity to
fund such payment, discussed below.
We have no interest rate or derivative hedging contracts and material foreign
exchange or commodity price risks. We are also not party to any
off-balance-sheet arrangements, other than operating leases.
We expect to incur significant operating expenses, particularly research and
development, for the foreseeable future in order to execute our business plan.
We, therefore, anticipate that such operating expenses, as well as planned
capital expenditures, will constitute a material use of our cash resources.
Although our existing cash and cash equivalents are expected to decline during
2003, we believe that our existing cash and cash equivalent balances, together
with our $25 million term loan and revolving line of credit, will be sufficient
to meet our operational plan for the next twelve months. We may, however, seek
additional financing through strategic alliances and/or equity markets to repay
the Teva deposit, if required, and to fund our research and development plans,
and potential revenues shortfall due to delays in new products introduction.
However, we may be unable to obtain such financing.
To date, we funded our research and development and other operating activities
through equity and debt financings, and strategic alliances.
We have not paid any cash dividends on our common stock and we do not plan to
pay any cash dividends in the foreseeable future. We plan to retain any earnings
for the operation and expansion of our business. Our loan agreements and our
strategic agreement with Teva prohibit the payment of dividends without the
other party's consent.
Recent Accounting Pronouncements
In August 2001, the Financial Accounting Standards Board ("FASB") issued SFAS
No. 143, "Accounting for Asset Retirement Obligations," which addresses
financial accounting and reporting for obligations associated with the
retirement of tangible long-lived assets and the associated asset retirement
costs. SFAS No. 143 applies to legal obligations associated with the retirement
of long-lived assets that result from the acquisition, construction, development
and/or normal use of the asset.
The Company adopted the provisions of SFAS No. 143 on January 1, 2003. Upon
initial application of the provisions of SFAS No. 143, entities are required to
recognize a liability for any existing asset retirement obligations adjusted for
cumulative accretion to the date of adoption of this Statement, an asset
retirement cost capitalized as an increase to the carrying amount of the
associated long-lived asset, and accumulated depreciation on that capitalized
cost. The provisions of this Statement did not and are not expected to have a
material impact on the Company's financial condition or results of operations.
In April 2002, the FASB issued SFAS No. 145, "Rescission of FASB Statements No.
4, 44, and 64, Amendment of FASB Statement No. 13, and Technical Corrections."
This Statement, which updates, clarifies and simplifies existing accounting
pronouncements, addresses the reporting of debt extinguishments and accounting
for certain lease modifications that have economic effects that are similar to
sale-leaseback transactions. The provisions of this Statement are generally
effective for the Company's 2003 fiscal year, or in the case of specific
provisions, for transactions occurring after May 15, 2002 or for financial
statements issued on or after May 15, 2002. The provisions of this Statement
have not had and are not expected to have a material impact on the Company's
financial condition or results of operations.
In July 2002 the FASB issued SFAS No. 146, "Accounting for Costs Associated with
Exit or Disposal Activities." This Statement addresses financial accounting and
reporting for costs associated with exit or disposal activities and nullifies
Emerging Issues Task Force Issue ("EITF") No. 94-3, "Liability Recognition for
Certain Employee Termination Benefits and Other Costs to Exit an Activity
(including Certain Costs Incurred in a Restructuring)." This Statement requires
that a liability for a cost associated with an exit or disposal activity be
recognized when the liability is incurred, and concludes that an entity's
commitment to an exit plan does not by itself create a present obligation that
meets the definition of a liability. This Statement also establishes that fair
value is the objective of initial measurement of the liability. The provisions
of this Statement are effective for exit or disposal activities that are
initiated after December 31, 2002, with early application encouraged. The
Company adopted SFAS No. 146 on January 1, 2003. The Company does not expect
that this Statement will have a material impact on the Company's financial
condition or results of operations.
In November 2002, the EITF reached a consensus on Issue No. 00-21, "Revenue
Arrangements with Multiple Deliverables." EITF Issue No. 00-21 provides guidance
on how to account for arrangements that involve the delivery or performance of
multiple products, services and/or rights to use assets. The provisions of EITF
Issue No. 00-21 will apply to revenue arrangements entered into in fiscal
periods beginning after June 15, 2003. The Company is currently evaluating the
effect that the adoption of EITF Issue No. 00-21 will have on its results of
operations and financial condition. The Company does not expect that this
Statement will have a material impact on the Company's financial condition or
results of operations.
Also in November 2002, the FASB issued FASB Interpretation No. 45 ("FIN 45"),
"Guarantor's Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others, an interpretation of FASB
Statements No. 5, 57 and 107 and Rescission of FASB Interpretation No. 34." FIN
45 clarifies the requirements of SFAS No. 5, "Accounting for Contingencies,"
relating to the guarantor's accounting for, and disclosure of, the issuance of
certain types of guarantees. The disclosure provisions of FIN 45 are effective
for the current fiscal year. The provisions for initial recognition and
measurement are effective on a prospective basis for guarantees that are issued
or modified after December 31, 2002, irrespective of a guarantor's year-end. We
reviewed all material agreements and concluded that all indemnifications are
excluded from the FIN No. 45 scope of interpretation since they relate primarily
to our own future performance and do not require any contingent payments.
In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based
Compensation - Transition and Disclosure, amendment of FASB Statement No. 123."
This statement provides additional transition guidance for those entities that
elect to voluntarily adopt the provisions of SFAS No. 123, "Accounting for Stock
Based Compensation." Furthermore, SFAS No. 148 mandates new disclosures in both
interim and year-end financial statements within the Company's Significant
Accounting Policies footnote. The Company has elected not to adopt the
recognition provisions of SFAS No. 123, as amended by SFAS No. 148. However, the
Company has adopted the disclosure provisions for the current fiscal year and
has included this information in Note 7 to the Company's financial statements.
In January 2003, the FASB issued FASB Interpretation No. 46 ("FIN 46"),
"Consolidation of Variable Interest Entities." FIN 46 clarifies the application
of Accounting Research Bulletin No. 51, "Consolidated Financial Statements," to
certain entities in which equity investors do not have the characteristics of a
controlling financial interest or do not have sufficient equity at risk for the
entity to finance its activities without additional subordinated financial
support from other parties. FIN 46 applies immediately to variable interest
entities created after January 31, 2003, and to variable interest entities in
which an enterprise obtains an interest after that date. It applies in the first
fiscal year or interim period beginning after June 15, 2003, to variable
interest entities in which an enterprise holds a variable interest that it
acquired before February 1, 2003. FIN 46 applies to public enterprises as of the
beginning of the applicable interim or annual period. IMPAX does not have any
relationships with variable interest entities as of March 31, 2003.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
The Company's investment portfolio consists of cash and cash equivalents and
marketable securities stated at cost which approximates market value. The
primary objective of the Company's investment activities is to preserve
principal while at the same time maximizing yields without significantly
increasing risk. To achieve this objective, the Company maintains its portfolio
in a variety of high credit quality securities, including U.S. Government
securities, treasury bills, short-term commercial paper, and highly rated money
market funds. One hundred percent of the Company's portfolio matures in less
than one year. The carrying value of the investment portfolio approximates the
market value at March 31, 2003. The Company's debt instruments at March 31,
2003, are subject to fixed interest rates and principal payments. We believe
that the fair value of our fixed rate long-term debt and refundable deposit
approximates their carrying value of approximately $39 million at March 31,
2003. While changes in market interest rates may affect the fair value of our
fixed rate long-term debt, we believe the effect, if any, of reasonably possible
near-term changes in the fair value of such debt on the Company's financial
statements will not be material.
We do not use derivative financial instruments and have no material foreign
exchange or commodity price risks.
ITEM 4. CONTROLS AND PROCEDURES
Within ninety days prior to the date of this quarterly report on Form 10-Q, the
Company, under the supervision and with the participation of our management,
including our principal executive officers and our principal financial officer,
evaluated the effectiveness of the design and operation of our disclosure
controls and procedures. Based on this evaluation, our principal executive
officers and our principal financial officer concluded that our disclosure
controls and procedures are effective to ensure that information required to be
disclosed by us in the reports that we file or submit under the Securities
Exchange Act of 1934 is recorded, processed, summarized, and reported within the
time period specified in the Securities and Exchange Commission's rules and
forms. In addition, subsequent to the date of the evaluation of our disclosure
controls and procedures, there were no significant changes in our internal
controls, or in other factors that could significantly affect these controls.
Company's management, including the Co-Chief Executive Officers and Chief
Financial Officer, does not expect that its Disclosure Controls or its "internal
controls and procedures for financial reporting" ("Internal Controls") will
prevent all error and all fraud. A control system, no matter how well conceived
and operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their costs. Because of the
inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if
any, within the Company have been detected. These inherent limitations include
the realities that judgments in decision-making can be faulty, and that
breakdowns can occur because of simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two
or more people, or by management override of the control. The design of any
system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions;
over time, control may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may deteriorate.
Because of the inherent limitations in a cost-effective control system,
misstatements due to error or fraud may occur and not be detected.
PART II - OTHER INFORMATION
----------------------------
ITEM 1. LEGAL PROCEEDINGS
Patent Litigation
There has been substantial litigation in the pharmaceutical, biological, and
biotechnology industries with respect to the manufacture, use, and sale of new
products that are the subject of conflicting patent rights. One or more patents
cover most of the brand name controlled-release products for which we are
developing generic versions. Under the Hatch-Waxman Amendments, when a drug
developer files an ANDA for a generic drug, and the developer believes that an
unexpired patent which has been listed with the FDA as covering that brand name
product will not be infringed by the developer's product or is invalid or
unenforceable, the developer must so certify to the FDA. That certification must
also be provided to the patent holder, who may challenge the developer's
certification of non-infringement, invalidity or unenforceability by filing a
suit for patent infringement within 45 days of the patent holder's receipt of
such certification. If the patent holder files suit, the FDA can review and
approve the ANDA, but is prevented from granting final marketing approval of the
product until a final judgment in the action has been rendered or 30 months from
the date the certification was received, whichever is sooner. Should a patent
holder commence a lawsuit with respect to an alleged patent infringement by us,
the uncertainties inherent in patent litigation make the outcome of such
litigation difficult to predict. The delay in obtaining FDA approval to market
our product candidates as a result of litigation, as well as the expense of such
litigation, whether or not we are successful, could have a material adverse
effect on our results of operations and financial position. In addition, there
can be no assurance that any patent litigation will be resolved prior to the
30-month period. As a result, even if the FDA were to approve a product upon
expiration of the 30-month period, we may be prevented from marketing that
product if patent litigation is still pending.
Litigation has been filed against us in connection with twelve of our Paragraph
IV filings. The outcome of such litigation is difficult to predict because of
the uncertainties inherent in patent litigation.
AstraZeneca AB et al. v. IMPAX: The Omeprazole Cases
-------------------------------
In May 2000, AstraZeneca AB and four of its related companies filed suit against
IMPAX in the United States District Court in Wilmington, Delaware claiming that
IMPAX's submission of an ANDA for Omeprazole Delayed Release Capsules, 10mg and
20 mg, constitutes infringement of six U.S. patents relating to AstraZeneca's
Prilosec product. The action seeks an order enjoining IMPAX from marketing
Omeprazole Delayed Release Capsules, 10mg and 20mg, until February 4, 2014, and
awarding costs and attorney fees. There is no claim for damages.
In February 2001, AstraZeneca and the same related companies filed the same suit
against IMPAX in the same federal court in Delaware for infringement, based upon
IMPAX's amendment to its ANDA adding 40mg strength Omeprazole Delayed Release
Capsules.
AstraZeneca filed essentially the same lawsuits against nine other generic
pharmaceutical companies (Andrx, Genpharm, Cheminor, Kremers, LEK, Eon, Mylan,
Apotex, and Zenith). Due to the number of these cases, a multidistrict
litigation proceeding, In re Omeprazole 10mg, 20mg, and 40mg Delayed Released
Capsules Patent Litigation, MDL-1291, has been established to coordinate
pre-trial proceedings. Both lawsuits filed by AstraZeneca et al. against IMPAX
have been transferred to the multidistrict litigation.
Early in the multidistrict litigation, the trial court ruled that one of the six
patents-in-suit was not infringed by the sale of a generic omeprazole product
and that another is invalid. In particular, the '794 patent (omeprazole in
combination with clarithromycin in the treatment of H.pylori); '305 (combination
therapy for H.pylori related disease); and the '342 patent (H.pylori treatment)
were declared invalid either in pre-trial summary proceedings or after the trial
described below. The trial court also ruled that the '499 (sulphenamide salt of
omeprazole) was not infringed in related summary proceedings. These rulings
effectively eliminated these four patents from the trial of these infringement
cases, although AstraZeneca may appeal these decisions as part of the overall
appeal process in the case.
On October 11, 2002, after a 52-day long trial involving Andrx, Genpharm,
Cheminor, and Kremers, the trial judge handling the multidistrict litigation
rendered a 277-page opinion that ruled on AstraZeneca's complaints that these
four defendants (the "First Wave Defendants") infringed the remaining
patents-in-suit. Most importantly, the trial judge ruled that three of the First
Wave defendants, Andrx, Genpharm, and Cheminor, infringed the '505 and '230
patents asserted by AstraZeneca in its complaints, and that those patents are
valid until 2007. The court construed the specific language of those two related
patents and found that each of these three First Wave Defendants proposed to
manufacture their generic equivalents of omeprazole using a process that
employed an Alkaline Reacting Compound, which the trial court said was defined
in the patent to include disodium hydrogen phosphate (a substance also used in
Impax's formulation), to create a "stabilizing" alkaline protective
"microenvironment" around active omeprazole particles in the "core region." The
trial court also construed the language of these patents to require that an
inert "subcoating" be "disposed" on the "core." The court said that the language
of the patents should be construed to mean that such a "subcoating" might be
created "in situ" by some reaction between elements of the "core" and an enteric
coating. The court held that the formulations employed by Andrx, Genpharm, and
Cheminor met these patent requirements as well, and that these three First Wave
defendants thus infringed both the '505 and '230 patents.
In the same ruling, the trial court ruled that the remaining First Wave
defendant, Kremers, did not infringe either the '505 or the '230 patent. This
defendant's formulation differed from the formulation used by the other First
Wave defendants in several respects. Among other things, the trial court's
opinion stated that Kremers does not use an Alkaline Reacting Compound in its
"core."
The formulation that IMPAX would employ in manufacturing its generic equivalent
of omeprazole has not been publicly announced. IMPAX's formulation has elements
that resemble those of other First Wave defendants, but it also has elements
that differ. Although the ruling by the trial court in the multidistrict
litigation has significant effect on the course of AstraZeneca's litigation
against IMPAX, application of the trial court's opinion is not certain. IMPAX
believes that it has defenses to AstraZeneca's claims of infringement, but the
opinion rendered by the trial court in the First Wave cases makes the outcome of
AstraZeneca's litigation against IMPAX less certain.
In December 2002, following proceedings before a Special Master appointed to
supervise discovery in the case, the trial court entered a new scheduling order
governing pre-trial proceedings relating to the six Second Wave defendants,
including IMPAX. The timing of further proceedings in this litigation may be
adversely affected by the appellate proceedings that have been commenced by
AstraZeneca and several of the First Wave Defendants. Under the scheduling order
entered by the court, discovery and pretrial proceedings have already commenced,
with the parties exchanging additional document requests and interrogatories.
Depositions of fact witnesses commenced on February 15, 2003 and, under the
scheduling order, must be completed by June 2003. Expert witness depositions
will occur thereafter and must be completed by mid-August 2003.
Two of the Second Wave defendants filed Motions for Summary Judgment of
Non-Infringement based upon Judge Jones' October 2002 ruling. The trial court
has deferred ruling on those motions until discovery is completed.
Under the scheduling order, any further Motions for Summary Judgment must be
filed by mid-September 2003 and will be heard by the trial court later in the
Fall of 2003. IMPAX may well file a Motion for Summary Judgment of
non-infringement following the close of discovery. If the case is not summarily
resolved (as by Summary Judgment), the case involving IMPAX will be returned to
the U.S. District Court in Delaware for trial. A possibility exists that the
case will be transferred back to New York for a consolidated trial before the
same judge who decided the First Wave cases. Trial will commence as soon as
practicable thereafter. If IMPAX does not file a Motion for Summary Judgment or
if such a motion is denied, IMPAX will press the court to schedule a date for
trial of the case in 2003, but no assurance can be given that trial will
commence at any particular time. IMPAX believes, however, that any trial that
might be scheduled in the case will commence no later than early 2004. IMPAX is
vigorously defending the action brought by AstraZeneca. IMPAX's defense of the
action is being conducted under an insurance policy issued by AIG, which pays a
portion of the costs of IMPAX's defense of AstraZeneca's suit (see "Insurance"
below). In March, 2001, AstraZeneca advised all of the defendants in the
multidistrict litigation that four new patents had been added to the FDA's
Orange Book as Omeprazole patents. IMPAX filed Paragraph IV certifications
asserting that, to its knowledge, its Omeprazole 10mg, 20mg, and 40mg Delayed
Released Capsules will not infringe valid claims of the four newly listed
patents. The forty-five (45) day period for AstraZeneca to file suit against
IMPAX under the four patents expired on August 6, 2001. AstraZeneca did not file
suit on these patents against IMPAX or any other generic company that filed
Paragraph IV certifications for these patents.
Abbott Laboratories et al. v. IMPAX: The Fenofibrate Capsule Cases
------------------------------------
In August 2000, Abbott Laboratories and Fournier Industrie et Santee and a
related company, filed suit against IMPAX in the United States District Court in
Chicago, Illinois claiming that IMPAX's submission of an ANDA for Fenofibrate
(Micronized) Capsules, 67mg, constitutes infringement of a U.S. patent owned by
Fournier and exclusively licensed to Abbott, relating to Abbott's TRICOR
product.
In December 2000, Abbott and Fournier filed a second action against IMPAX in the
same court making the same claims against IMPAX's 200mg Fenofibrate (Micronized)
capsules. A third action was filed for IMPAX's 134mg Fenofibrate (Micronized)
Capsules in March 2001. All three actions seek an injunction preventing IMPAX
from marketing its fenofibrate products until January 19, 2009, and an award of
damages for any commercial manufacture, use, or sale of IMPAX's fenofibrate
product, together with costs and attorney fees.
Abbott and Fournier have filed essentially the same lawsuits against Novopharm
and Teva, also in the U.S. District Court in Chicago.
IMPAX responded to the complaints by filing an answer asserting that its
proposed generic fenofibrate product does not infringe the patent-in-suit and by
asserting that the patent-in-suit is invalid and not enforceable against IMPAX.
In March 2002, Judge Darrah granted Novopharm's Motion for Summary Judgment of
Non-Infringement. The grounds for finding non-infringement by Novopharm were
directly applicable to IMPAX. IMPAX filed its own Motion for Summary Judgment of
Non-Infringement before Judge Gottschall, the judge who is presiding over the
IMPAX case.
In March 2003, the Court of Appeals for the Federal Circuit affirmed the grant
of Novopharm's Motion for Summary Judgment of Non-Infringement. Shortly
thereafter, Judge Gottschall granted IMPAX's Motion for Summary Judgment of
Non-Infringement.
Abbott and Fournier have filed a petition requesting a rehearing before the
Federal circuit in its appeal in the Novopharm case. Judge Gottschall has
entered an order delaying entry of final judgment in the IMPAX case until the
Federal Circuit rules on the petition for rehearing.
IMPAX expects the petition for rehearing will be denied by the Federal Circuit
and a final judgment of non-infringement will be entered in favor of IMPAX by
Judge Gottschall in the near future.
GlaxoSmithKline (Glaxo) v. IMPAX: The Bupropion Cases
---------------------------------
Glaxo filed a Complaint (Case No. 00-04403) against IMPAX in the United States
District Court for the Northern District of California on November 3, 2000
alleging infringement of U.S. Patent No. 5,427,798 covering Wellbutrin SR/Zyban.
On November 7, 2000, IMPAX filed its Answer to the Complaint which included
defenses to the infringement claim, and counterclaimed for patent invalidity.
Glaxo has filed suit against Andrx, Watson, Eon (only with regard to Wellbutrin
SR) and Excel for similar ANDA filings.
All parties attended a Status Conference in July 2001 to discuss the need for a
Markman (claim construction) Hearing. IMPAX was successful in convincing the
Court that a Markman Hearing was unnecessary because there was no literal
infringement and no dispute regarding the Claim Construction proffered by Glaxo.
Instead, IMPAX advocated that our Summary Judgment Motion, based upon
prosecution history estoppel grounds, be calendared for oral argument. The
parties completed the briefing on this issue and oral argument was held on
November 19, 2001. At the request of the Court, in July 2002, both sides
submitted briefs on the impact of the recent Supreme Court decision in Festo v.
Shoketsu Kinzoku Kogyo Kabushi Co., et al. to the pending Motion for Summary
Judgment. An additional Motion for Summary Judgment was brought in early August
2002, requesting Judge Patel apply the District Court for the Eastern District
of Virginia's decision limiting the scope of the `798 patent in the Glaxo v.
Excel case to IMPAX's ANDA formulation.
On August 21, 2002, Judge Patel granted IMPAX's motions for Summary Judgment,
stating that "prosecution estoppel bars infringement by equivalents throughout
the `798 patent." Glaxo has appealed Judge Patel's decision to the Court of
Appeals for the Federal Circuit and that appeal was fully briefed on January 22,
2003. Oral argument on the appeal is scheduled for June 2003, after which IMPAX
expects a decision on the appeal. The defense costs in this litigation are
covered under an insurance policy issued by AIG (see "Insurance" below).
Previously, Glaxo had decided to settle its Bupropion Hydrochloride 100mg and
150mg Extended Release Tablets litigation with Watson Pharmaceuticals on terms
that are confidential.
Schering-Plough Corporation v. IMPAX: The Loratadine Cases
-------------------------------------
On January 2, 2001, Schering-Plough Corporation ("Schering-Plough") sued IMPAX
in the United States District Court for the District of New Jersey (Case No.
01-0009), alleging that IMPAX's proposed Loratadine and Pseudoephedrine Sulfate
24-hour Extended Release Tablets, containing 10mgs of loratadine and 240mgs of
pseudoephedrine sulfate, infringe U.S. Patent Nos. 4,659,716 (the "'716 patent")
and 5,314,697 (the "'697 patent"). Schering-Plough has sought to enjoin IMPAX
from obtaining FDA approval to market its 24-hour extended release tablets until
the `697 patent expires in 2012. Schering-Plough has also sought monetary
damages should IMPAX use, sell or offer to sell its loratadine product prior to
the expiration of the `697 patent. IMPAX filed its Answer to the Complaint on
February 1, 2001, and IMPAX has denied that it infringes any valid and/or
enforceable claim of the `716 or `697 patent.
On January 18, 2001, Schering-Plough sued IMPAX in the United States District
Court for the District of New Jersey (Case No. 01-0279), alleging that IMPAX's
proposed orally-disintegrating loratadine tablets ("Reditabs") infringe claims
of the '716 patent. Schering-Plough has sought to enjoin IMPAX from obtaining
approval to market its Reditab products until the `716 patent expires in 2004.
Schering-Plough has also sought monetary damages should IMPAX use, sell, or
offer to sell its loratadine product prior to the expiration of the `716 patent.
IMPAX filed its Answer to the Complaint on February 27, 2001, and has denied
that it infringes any valid or enforceable claim of the `716 patent.
On February 1, 2001, Schering-Plough sued IMPAX in the United States District
Court for the District of New Jersey (Case No. 01-0520), alleging that IMPAX's
proposed Loratadine and Pseudoephedrine Sulfate 12-hour Extended Release
Tablets, containing 5mgs of loratadine and 120mgs of pseudoephedrine sulfate,
infringe claims of the '716 patent. Schering-Plough has sought to enjoin IMPAX
from obtaining approval to market its 12-hour extended release tablets until the
`716 patent expires in 2004. Schering-Plough has also sought monetary damages
should IMPAX use, sell, or offer to sell its loratadine product prior to the
expiration of the `716 patent. IMPAX filed its Answer to the Complaint on
February 27, 2001 and has denied that it infringes any valid or enforceable
claim of the `716 patent.
These three cases have been consolidated for the purposes of discovery with
seven other cases in the District of New Jersey in which Schering-Plough sued
other corporations who have sought FDA approval to market generic loratadine
products.
Fact discovery and expert discovery on issues related to the `716 patent have
ended. In accordance with the schedule set by the Court, the parties filed
Initial Dispositive Motions on issues related to the `716 patent on October 31,
2001 - and these motions were fully briefed December 2001. Oral argument on two
of the Dispositive Motions took place before Judge Bissell on June 26, 2002. On
August 8, 2002, Judge Bissell granted Defendants' Motion for Summary Judgment
that Claims 1 and 3 of the `716 Patent are inherently anticipated by
Schering-Plough's '233 Patent and denied Schering-Plough's Motion for Summary
Judgment on Defendants' inherent anticipation defenses and counterclaims. The
Court held that Claims 1 and 3 of the `716 patent - the claims of that patent
that Schering-Plough asserted against IMPAX in Case Nos. 01-0009, 01-0279,
01-0520 - are invalid. Schering-Plough has appealed Judge Bissell's decision to
the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit heard
oral argument on Schering's appeal on April 8, 2003. The parties await the
Federal Circuit decision.
In Case No. 01-0009, fact discovery on the `697 patent is completed and expert
discovery on the `697 patent was completed on January 24, 2003. The Court has
not yet entered a schedule for Briefing Dispositive Motions on the `697 patent.
The defense costs in this litigation are covered under an insurance policy
issued by AIG (see "Insurance" below).
Aventis Pharmaceuticals Inc., et al. v. IMPAX: The Fexofenadine Cases
----------------------------------------------
On March 25, 2002, Aventis Pharmaceuticals Inc., Merrell Pharmaceuticals Inc.,
and Carderm Capital L.P. (collectively "Aventis") sued IMPAX in the United
States District Court for the District of New Jersey (Civil Action No.
02-CV-1322) alleging that IMPAX's proposed fexofenadine and pseudoephedrine
hydrochloride tablets, containing 60mg of fexofenadine and 120mg of
pseudoephedrine hydrochloride, infringe United States Patent Nos. 6,039,974;
6,037,353; 5,738,872; 6,187,791; 5,855,912; and 6,113,942. On November 7, 2002,
Aventis filed an amended complaint, which added an allegation that IMPAX's
Fexofenadine and Pseudoephedrine Hydrochloride 60mg/120mg Extended Release
Tablet product infringes United States Patent No. 6,399,632. Aventis seeks an
injunction preventing IMPAX from marketing its Fexofenadine and Pseudoephedrine
Hydrochloride 60mg/120mg Extended Release Tablet product until the
patents-in-suit have expired, and an award of damages for any commercial
manufacture, use, or sale of IMPAX's Fexofenadine and Pseudoephedrine
Hydrochloride 60mg/120mg Extended Release Tablet product, together with costs
and attorneys' fees.
On March 26, 2002, Aventis filed a virtually identical complaint against IMPAX
in the United States District Court for the District of Delaware (Civil Action
No. 02-226). The Delaware complaint was filed in case Aventis could not obtain
personal jurisdiction over IMPAX in New Jersey. On May 8, 2002, IMPAX moved to
dismiss the New Jersey action for lack of personal jurisdiction. On December 18,
2002, IMPAX's Motion to Dismiss the action in New Jersey was denied. On December
19, 2002, a stipulation dismissing the Delaware action without prejudice was
filed.
Because of the pending procedural motions, discovery is in its early stages.
IMPAX believes, however, that it has strong defenses to the claims made by
Aventis based on noninfringement and invalidity. The Court has scheduled trial
for September 2004.
Aventis has also filed a suit against Barr Laboratories, Inc. in New Jersey
asserting the same patents against Barr's proposed Fexofenadine and
Pseudoephedrine Hydrochloride 60mg/120mg Extended Release Tablet product. The
IMPAX case will be coordinated with the Barr case for discovery purposes, but it
has not yet been decided whether the two will be consolidated for trial.
Purdue Pharma L.P. et al. v IMPAX: The Oxycodone Cases
----------------------------------
On April 11, 2002, Purdue Pharma and related companies filed a complaint in the
United States District Court for the Southern District of New York alleging that
IMPAX's submission of ANDA No. 76-318 for 80mg OxyContin Tablets infringes three
patents owned by Purdue. The Purdue patents are U.S. 4,861,598, U.S. 4,970,075
and U.S. 5,266,331, all directed to controlled release opiod formulations. On
September 19, 2002, Purdue filed a second Infringement Complaint regarding
IMPAX's 40mg OxyContin generic product. On October 9, 2002, Purdue filed a third
Infringement Complaint regarding IMPAX's 10mg and 20mg OxyContin generic
products. Purdue is seeking, among other things, a court order preventing IMPAX
from manufacturing, using or selling any drug product that infringes the subject
Purdue patents. IMPAX is currently disputing the jurisdiction of the United
States District Court for the Southern District of New York in which Purdue has
brought this matter by pursuing a Motion to Dismiss Purdue's action. As of April
19, 2003, the court has not ruled on IMPAX's pending motion.
Purdue previously sued Boehringer Ingelheim/Roxane, Endo and Teva on the same
patents. It is likely that one or more of these other defendants will resolve
the invalidity issues surrounding the Purdue patents prior to IMPAX going to
trial. The Boehringer Ingelheim/Roxane suit is stayed. The Endo action is
scheduled to go to trial in June of 2003.
These are patent infringement actions relating to IMPAX's Abbreviated New Drug
Application (ANDA) for approval to market generic versions of Purdue's
OxyContin(R). All three actions are in their early stages. We are contesting
these patent infringement actions vigorously. While it is difficult to predict
the outcome of litigation, especially hotly contested litigations such as these,
we believe that IMPAX has a solid position. Due to the nature of ANDA patent
litigation, monetary damages cannot be awarded against IMPAX merely for filing
the ANDA. If IMPAX lost all these actions and, in addition, was found to have
willfully infringed Purdue's patents, IMPAX could be liable for Purdue's
attorneys' fees.
IMPAX v. Aventis Pharmaceuticals, Inc.: The Riluzole Case
---------------------------------------
In June 2002, IMPAX filed suit against Aventis Pharmaceuticals, Inc. in the
United States District Court in Wilmington, Delaware, seeking a declaration that
the filing of an Abbreviated New Drug Application to engage in a commercial
manufacture and/or sale of Riluzole 50mg Tablets for treatment of patients with
amyotrophic lateral scleroses ("ALS") does not infringe claims of Aventis' U.S.
Patent No. 5,527,814 ("the `814 patent") and a declaration that this patent is
invalid.
In response to IMPAX's complaint, Aventis filed counterclaims for direct
infringement and inducement of infringement of the `814 patent. In December
2002, the district court granted Aventis' Motion for Preliminary Injunction and
enjoined IMPAX from infringing, contributory infringing, or inducing any other
person to infringe Claims 1, 4 or 5 of the `814 patent by selling, offering for
sale, distributing, marketing or exporting from the United States any
pharmaceutical product or compound containing riluzole or salt thereof for the
treatment of ALS.
The parties are currently engaged in the discovery phase of the action. A trial
for the matter has been scheduled for early in the fourth quarter of 2003.
If IMPAX is not ultimately successful in proving invalidity or unenforceability,
there is a substantial likelihood that the court will enter a Permanent
Injunction enjoining IMPAX from marketing Riluzole 50mg Tablets for the
treatment of ALS in the United States until the expiration of the `814 patent
(June 18, 2013). If IMPAX is ultimately successful in proving either defense,
the Preliminary Injunction would be set aside and IMPAX would be permitted to
market its Riluzole 50mg Tablet product for the treatment of ALS in the United
States.
Abbott Laboratories v. IMPAX: The Fenofibrate Tablet Cases
-----------------------------
In January 2003, Abbott Laboratories and Fournier Industrie et Sante and a
related company filed suit against IMPAX in the United States District Court in
Wilmington, Delaware claiming that IMPAX's submission of an ANDA for Fenofibrate
tablets, 160mg, constitutes infringement of two U.S. patents owned by Fournier
and exclusively licensed to Abbott, relating Abbott's Tricor(R) tablet product.
In March 2003, Abbott and Fournier filed a second action against IMPAX in the
same court making the same claims against IMPAX's 54mg Fenofibrate tablets. Both
actions seek an injunction preventing IMPAX from marketing its fenofibrate
tablet products until the expiration of the patents and an award of damages for
any commercial manufacture, use, or sale of IMPAX's fenofibrate tablet product,
together with costs and attorney fees.
Abbott and Fournier have filed essentially the same lawsuits against Teva, also
in the U.S. District Court in Wilmington, Delaware.
IMPAX has responded to the complaints by asserting that its proposed generic
fenofibrate tablet product does not infringe the patents-in-suit and by
asserting that the patents-in-suit are invalid.
In April 2003, the court ordered the consolidation of the two IMPAX cases and
entered a schedule in which trial of the consolidated cases would occur in the
first quarter of 2005.
Merck & Co., Inc. v. IMPAX: The Carbidopa and Levodopa Case
---------------------------
On February 24, 2003, Merck & Co., Inc. filed a lawsuit against the Company in
the United States District Court in Delaware alleging patent infringement
related to IMPAX's filing of an ANDA for a generic version of Sinemet CR
Tablets.
On April 8, 2003, Merck & Co., Inc. withdrew its lawsuit alleging patent
infringement related to our filing of the ANDA for a generic version of
Sinemet(R)CR Tablets.
Solvay Pharmaceuticals v. IMPAX: The Creon(R) Case
--------------------------------------------------
In April 2003, Solvay Pharmaceuticals, Inc., manufacturer of the Creon(R) line
pancreatic enzyme products, brought suit against the Company in the U.S.
District Court for the District of Minnesota claiming that the Company has
engaged in false advertising, unfair competition, and unfair trade practices
under federal and Minnesota law in connection with the Company's marketing and
sale of its Lipram products. The suit seeks actual and consequential damages,
including treble damages, attorneys fees, injunctive relief and declaratory
judgments that would prohibit the substitution of Lipram for prescriptions of
Creon. The Company believes the allegations are without merit and intends to
defend this suit vigorously.
Other than the patent litigations described above, we are not aware of any other
material pending or threatened legal actions, private or governmental, against
us. However, as we file additional applications with FDA that contain Paragraph
IV certifications, it is likely we will become involved in additional litigation
related to those filings.
Insurance
As part of our patent litigation strategy, we have obtained two policies
covering up to $7 million of patent infringement liability insurance from
American International Specialty Line Company ("AISLIC"), an affiliate of AIG
International. This litigation insurance covers us against the costs associated
with patent infringement claims made against us relating to seven of the ANDAs
we filed under Paragraph IV of the Hatch-Waxman Amendments. At present, we
believe this insurance coverage is sufficient for our legal defense costs
related to these seven ANDAs. Correspondence received from AISLIC indicated
that, as of April 10 and 17, 2003, one of the policies had approximately
$1,651,000 remaining on the limit of liability and the second of the policies
had approximately $639,000 remaining on the limit of liability. In addition, as
per the agreement with Teva, for the six products already filed at the time of
the agreement, Teva will pay 50% of the attorneys' fees and costs in excess of
the $7 million to be paid by AISLIC. For the three products filed since the
agreement was signed, Teva will pay 45% of the attorneys' fees and costs, and
for the remaining three products, Teva will pay 50% of the attorneys' fees and
costs.
However, we do not believe that this type of litigation insurance will be
available to us on acceptable terms for our other current or future ANDAs. In
those cases, our policy is to record such expenses as incurred.
Product liability claims by customers constitute a risk to all pharmaceutical
manufacturers. We carry $10 million of product liability insurance for our own
manufactured products. This insurance may not be adequate to cover any product
liability claims to which we may become subject.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
o 99.1 - Certification Pursuant to 18 U.S.C. Section 1350 as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002
(b) Reports
o The Company filed on February 12, 2003 a report on Form
8-K announcing earnings for the quarter and year ended
December 31, 2002.
o The Company filed on February 24, 2003 a report on Form
8-K announcing that Merck & Co. had filed a lawsuit
against IMPAX alleging patent infringement related to
IMPAX's filing of an ANDA for Sinemet(R) CR Tablets.
o The Company filed on March 31, 2003 a report on Form 8-K
announcing that the U.S. District Court of Chicago ruled
IMPAX's fenofibrate capsules, a generic form of Tricor(R)
Capsules, does not infringe on Abbott Laboratories' patent
on this product.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
IMPAX LABORATORIES, INC.
By: /s/ BARRY R. EDWARDS April 29, 2003
------------------------------------ --------------
Co-Chief Executive Officer
(Principal Executive Officer)
By: /s/ CORNEL C. SPIEGLER April 29, 2003
-------------------------------------------- --------------
Chief Financial Officer
(Principal Financial and Accounting Officer)
CERTIFICATION OF
Co-CHIEF EXECUTIVE OFFICER
I, Charles Hsiao, Chairman & Co-CEO, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the three months
ended March 31, 2003 of Impax Laboratories, Inc.
2. Based on my knowledge, this quarterly report does not contain any
untrue statement of a material fact, or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading, with respect to
the period covered by this quarterly report.
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present, in all
material respects, the financial condition, results of operations, and
cash flows of the registrant as of, and for, the periods presented in
this quarterly report.
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant,
and we have:
a) designed such disclosure controls and procedures to ensure
that material information relating to the registrant,
including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during
the period in which this quarterly report is being
prepared;
b) evaluated the effectiveness of the registrant's disclosure
controls and procedures as of a date within 90 days prior
to the filing date of this quarterly report (the
"Evaluation Date"); and
c) presented in this quarterly report our conclusions about
the effectiveness of the disclosure controls and
procedures based on our evaluation as of the Evaluation
Date.
5. The registrant's other certifying officers and I have disclosed, based
on our most recent evaluation, to the registrant's auditors and the
Audit Committee of registrant's Board of Directors (or persons
performing the equivalent function):
a) all significant deficiencies in the design or operation of
internal controls which could adversely affect the
registrant's ability to record, process, summarize, and
report financial data, and have identified for the
registrant's auditors any material weaknesses in internal
controls; and
b) any fraud, whether or not material, that involves
management or other employees who have a significant role
in the registrant's internal controls.
6. The registrant's other certifying officers and I have indicated in this
quarterly report whether or not there were significant changes in
internal controls, or in other factors that could significantly affect
internal controls, subsequent to the date of our most recent
evaluation, including any corrective actions with regard to significant
deficiencies and material weaknesses.
/s/ Charles Hsiao, Ph.D.
---------------------------------------
Charles Hsiao, Ph.D.
Chairman and Co-Chief Executive Officer
April 29, 2003
---------------------------------------
CERTIFICATION OF
Co-CHIEF EXECUTIVE OFFICER
I, Barry R. Edwards, Co-CEO, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the three months
ended March 31, 2003 of Impax Laboratories, Inc.
2. Based on my knowledge, this quarterly report does not contain any
untrue statement of a material fact, or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading, with respect to
the period covered by this quarterly report.
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present, in all
material respects, the financial condition, results of operations, and
cash flows of the registrant as of, and for, the periods presented in
this quarterly report.
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant,
and we have:
a) designed such disclosure controls and procedures to ensure
that material information relating to the registrant,
including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during
the period in which this quarterly report is being
prepared;
b) evaluated the effectiveness of the registrant's disclosure
controls and procedures as of a date within 90 days prior
to the filing date of this quarterly report (the
"Evaluation Date"); and
c) presented in this quarterly report our conclusions about
the effectiveness of the disclosure controls and
procedures based on our evaluation as of the Evaluation
Date.
5. The registrant's other certifying officers and I have disclosed, based
on our most recent evaluation, to the registrant's auditors and the
Audit Committee of registrant's Board of Directors (or persons
performing the equivalent function):
a) all significant deficiencies in the design or operation of
internal controls which could adversely affect the
registrant's ability to record, process, summarize, and
report financial data, and have identified for the
registrant's auditors any material weaknesses in internal
controls; and
b) any fraud, whether or not material, that involves
management or other employees who have a significant role
in the registrant's internal controls.
6. The registrant's other certifying officers and I have indicated in this
quarterly report whether or not there were significant changes in
internal controls, or in other factors that could significantly affect
internal controls, subsequent to the date of our most recent
evaluation, including any corrective actions with regard to significant
deficiencies and material weaknesses.
/s/ Barry R. Edwards
--------------------------
Barry R. Edwards
Co-Chief Executive Officer
April 29, 2003
--------------------------
CERTIFICATION OF
CHIEF FINANCIAL OFFICER
I, Cornel C. Spiegler, CFO, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the three months
ended March 31, 2003 of Impax Laboratories, Inc.
2. Based on my knowledge, this quarterly report does not contain any
untrue statement of a material fact, or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading, with respect to
the period covered by this quarterly report.
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present, in all
material respects, the financial condition, results of operations, and
cash flows of the registrant as of, and for, the periods presented in
this quarterly report.
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant,
and we have:
a) designed such disclosure controls and procedures to ensure
that material information relating to the registrant,
including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during
the period in which this quarterly report is being
prepared;
b) evaluated the effectiveness of the registrant's disclosure
controls and procedures as of a date within 90 days prior
to the filing date of this quarterly report (the
"Evaluation Date"); and
c) presented in this quarterly report our conclusions about
the effectiveness of the disclosure controls and
procedures based on our evaluation as of the Evaluation
Date.
5. The registrant's other certifying officers and I have disclosed, based
on our most recent evaluation, to the registrant's auditors and the
Audit Committee of registrant's Board of Directors (or persons
performing the equivalent function):
a) all significant deficiencies in the design or operation of
internal controls which could adversely affect the
registrant's ability to record, process, summarize, and
report financial data, and have identified for the
registrant's auditors any material weaknesses in internal
controls; and
b) any fraud, whether or not material, that involves
management or other employees who have a significant role
in the registrant's internal controls.
6. The registrant's other certifying officers and I have indicated in this
quarterly report whether or not there were significant changes in
internal controls, or in other factors that could significantly affect
internal controls, subsequent to the date of our most recent
evaluation, including any corrective actions with regard to significant
deficiencies and material weaknesses.
/s/ Cornel C. Spiegler
------------------------
Cornel C. Spiegler
Chief Financial Officer
April 29, 2003
------------------------